Policy & Regulation
Puma Biotechnology announces receipt by licensing partner of regulatory approval from Health Canada to commercialise NERLYNX for extended adjuvant treatment of HER2-positive early stage breast cancer
17 July 2019 -

Puma Biotechnology Inc (Nasdaq: PBYI) announced on Tuesday the receipt of marketing authorisation from Health Canada, by its licensing partner Knight Therapeutics Inc (Knight), to commercialise NERLYNX (neratinib) in Canada for the extended adjuvant treatment of women with early stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.

With this approval by Health Canada, Neratinib becomes the first anti-HER2 treatment to be approved in Canada, as extended adjuvant therapy for women with early stage HR-positive, HER2-positive breast cancer following adjuvant trastuzumab-based therapy.

Reportedly, Health Canada's approval was based on the phase III ExteNET trial, a multicentre, randomised, double-blind, placebo-controlled trial of neratinib following adjuvant trastuzumab treatment. Women with early stage HER2-positive breast cancer and within two years of completing adjuvant trastuzumab therapy were randomised to receive either neratinib or placebo for one year.

According to the company, the results of the ExteNET trial demonstrated that after two years of follow-up, for patients with hormone receptor positive, HER2-positive early stage breast cancer patients who were treated within one year after the completion of trastuzumab based adjuvant therapy, invasive disease-free survival (iDFS) was 95.3% in the patients treated with neratinib compared with 90.8% in those receiving placebo.

The most common adverse reactions (less than 5%) were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight loss, and urinary tract infection. The most common adverse reaction leading to discontinuation was diarrhoea, which was observed in 16.8% of neratinib-treated patients. Hepatotoxicity or increases in liver transaminases led to drug discontinuation in 1.7% of neratinib-treated patients.

Puma Biotechnology is a biopharmaceutical company with a focus on the development and commercialisation of innovative products to enhance cancer care.

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